[Federal Register Volume 63, Number 125 (Tuesday, June 30, 1998)]
[Notices]
[Pages 35589-35592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 98035]
Epidemiologic Research Studies of Acquired Immunodeficiency
Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection Notice
of Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1998 funds for new and competitive
continuation cooperative agreements for epidemiologic and behavioral
research studies of AIDS and HIV infection. This program addresses the
``Healthy People 2000'' priority area of HIV Infection. These awards
will help support researchers in the conduct of HIV-related
epidemiologic research studies that foster prevention of HIV infection
or HIV-related disease in children. These include studies that address
the follow-up of HIV-infected children and other HIV epidemiologic
studies.
Research Issue: HIV Infection in Children--Follow Up of Perinatally-
Infected Children
Applications are solicited for continued prospective follow-up of
HIV-infected children enrolled in the Perinatal AIDS Collaborative
Transmission Study (PACTS) between 1986 and 1998. This is a research
issue of programmatic interest to the health care community and to CDC
for FY 1998. This issue is considered significant to gaining a greater
understanding of the epidemiology of AIDS and HIV infection. Follow-up
should be done at least every 3 months, and include: (1) collecting
information on HIV-related clinical conditions, HIV-related medication
use, hospitalizations, and vital status; and (2) collecting blood
specimens for viral load testing, lymphocyte immunophenotyping, and
storage for other HIV-related testing. Applicants will use a common
data collection instrument, protocol, and data management system
designed and implemented in collaboration with CDC.
Applications submitted by organizations that examine additional
important HIV-related epidemiologic research issues will also be
accepted and considered for funding.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
C. Availability of Funds
Approximately $4.5 million is available in FY 1998 to fund
approximately 6 awards. It is expected that awards will range from
$250,000 to $1.5 million. It is expected that 4 projects addressing HIV
infection in children and 2 other HIV epidemiologic studies will be
funded. Awards will begin on or about September 29, 1998, and will be
made for a 12-month budget period, within a project period of up to 3
years. Funding estimates may change.
Funding Preferences
Preference will be given to competing continuation applications
from satisfactorily performing projects over applications for projects
not already receiving support under the program.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed under
``Recipient Activities,'' below, and CDC will be responsible for
conducting activities listed under ``CDC Activities'', below:
Recipient Activities
Applicants addressing the same research issue should be willing to
participate in collaborative studies with other CDC-sponsored
researchers, including using common data collection instruments,
specimen collection protocols, and data management procedures, as
determined in post-award grantee planning conferences. Applicants will
be required to pool data for analysis and publication. Applicants are
also required to:
A. Develop the research study protocol and data collection forms.
B. Identify, recruit, obtain informed consent from, and enroll an
adequate number of study participants as determined by the study
protocol and the program requirements.
C. Continue to follow study participants as determined by the study
protocol.
D. Establish procedures to maintain the rights and confidentiality
of all study participants.
E. Perform laboratory tests (when appropriate) and data analysis as
determined in the study protocol.
[[Page 35590]]
F. Collaborate and share data and specimens (when appropriate) with
other collaborators to answer specific research questions.
G. Conduct data analysis with all collaborators as well as present
and publish research findings.
CDC Activities
A. Provide technical assistance in the design and conduct of the
research.
B. Provide technical guidance in the development of study
protocols, consent forms, and data collection forms.
C. Assist in designing a data management system.
D. Assist in performance of selected laboratory tests.
E. Coordinate research activities among the different sites.
F. Assist in the analysis of research information and the
presentation and publication of research findings.
E. Application Content
Competing Applications (New Applications and Competing Continuation
Applications)
Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan.
Applicants should identify their proposed research issue on line
one of the face page of the application form. Applicants must
demonstrate adequate capacity for continued follow-up of children,
routine virologic and immunologic testing, data management, and
specimen storage. Applicants also must demonstrate the capacity to
analyze data and specimens collected in the PACTS project to address
important issues related to preventing HIV infection and its
manifestations in children, and provide proposed analyses to be
completed during the project period.
In future years, noncompeting continuation applications submitted
within the approved project period should include:
A. brief progress report describing the accomplishments of the
preceding budget period;
B. new or significantly revised items or information (objectives,
scope of activities, operational methods, evaluation), that is, not in
the initial application; and
C. annual budget and justification (budget items that are unchanged
from the preceding budget period do not need rejustification, simply
list the items in the budget and note that they are continuation
items).
F. Submission and Deadline
On or before JULY 31, 1998, submit the original and five copies of
PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the
Errata Instruction Sheet for PHS 398) to: Kevin Moore, Grants
Management Specialist, Grants Management Branch, Procurement and Grants
Office, Announcement 98035, Centers for Disease Control and Prevention
(CDC), 255 East Paces Ferry Road, N.E., Room 300, Mail Stop E-15,
Atlanta, Georgia 30305-2209.
Applications must be postmarked by the U.S. Postal Service or a
commercial carrier by the deadline date. If your application does not
arrive in time for submission to the independent review panel, it will
not be considered in the current competition unless you can provide
proof that you mailed it on or before the deadline (i.e., receipt from
U.S. Postal Service or a commercial carrier; private metered postmarks
are not acceptable).
G. Evaluation Criteria
Each application will be evaluated individually against the
following criteria by an independent reviewer group appointed by CDC.
Applicants will be ranked on a scale of 100 maximum points according to
the research area identified. All applicants must state which research
category they are addressing. Applicants should demonstrate the
applicant's ability to address the research problem in a collaborative
manner with other collaborators. Applications will be reviewed and
evaluated based on the evidence submitted.
HIV Infection in Children
A. Recruitment, Retention, and Adherence to Study Protocol (20 Points)
(1) Extent of applicant's experience in perinatal and pediatric HIV
infection epidemiologic research.
(2) Evidence of ability to successfully follow HIV-infected
children in longitudinal research studies.
(3) Evidence of ability to collect complete data from HIV-infected
children.
B. Description and Justification of Research Plans (30 Points)
(1) Extent of familiarity and quality of experience pertinent to
proposed research activities.
(2) Understanding of the research objectives as evidenced by high
quality of the proposed plan for research and a study design that is
appropriate to answer research questions.
(3) Originality of research, extent to which it does not replicate
past or present research efforts, and direct relevance of research to
guiding current efforts to prevent perinatal HIV transmission and HIV
disease progression in children.
(4) Feasibility of plans to follow study participants, and adequacy
of sample size to address research questions. This includes
demonstration of the experience of the investigator in enrolling and
following such persons, and the comprehensiveness of the plan to
protect the rights and confidentiality of all participants.
(5) Thoroughness of plans for data management, data analysis, and
laboratory analysis; reasonableness of data collected; and statistical
rigor.
(6) Extent to which proposal demonstrates feasible plans for
coordinating research activities of multiple clinical sites, where
appropriate, and with CDC. Letters of support from cooperating
organizations that demonstrate the nature and extent of such
cooperation should be included.
(7) The degree to which the applicant has met the CDC Policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research. This includes: (a) The proposed plan
for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation; (b) the proposed
justification when representation is limited or absent; (c) a statement
as to whether the design of the study is adequate to measure
differences when warranted; and (d) a statement as to whether the plans
for recruitment and outreach for study participants include the process
of establishing partnerships with community(ies) and recognition of
mutual benefits.
C. Research Capability (30 Points)
(1) Capacity to conduct study as evidenced by quality of experience
with similar or related research as evidenced by previous related
research, including demonstration of ability to collect, manage, and
analyze accurate data in a timely manner.
(2) Demonstration of working relationships with proposed
collaborators.
(3) Demonstration of epidemiologic, behavioral, administrative,
clinical, laboratory, data management, and statistical expertise needed
to conduct proposed research.
[[Page 35591]]
D. Staffing, Facilities, and Time-line (20 Points)
(1) Availability of qualified personnel with realistic and
sufficient percentage-time commitments, and the clarity of the
descriptions of the duties and responsibilities of project personnel.
(2) Adequacy of plans for project oversight to assure quality of
data.
(3) Adequacy of facilities, equipment, data processing and analysis
capacity, and systems for management of data security and participant
confidentiality.
(4) Adequacy of time line for completion of project activities.
E. Other (not Scored)
(1) Budget: Will be reviewed to determine the extent to which it is
reasonable, clearly justified, consistent with the intended use of
funds, and allowable. All budget categories should be itemized.
(2) Human Subjects: Does the application adequately address the
institutional review board requirements for the protection of human
subjects?
________ Yes ________ No
Comments:--------------------------------------------------------------
Other HIV/AIDS Epidemiologic Research Studies
A. Familiarity With and Access to Study Population (25 Points)
(3) Extent of applicant's knowledge of issues faced by study
population and experience in working with this population.
(4) Existence of linkages to facilitate recruitment from and
referral to programs providing services for the study population and
letters of support from these programs.
(5) Feasibility of plans to involve the study population, their
advocates, or service providers in the development of research and
intervention activities and to inform them of research results.
(6) Evidence that plans for recruitment of and outreach for study
participants will include establishing partnerships with communities.
B. Description and Justification of a Research Plan (40 Points)
(1) Quality of the review of the scientific literature pertinent to
the proposed study, including theoretical basis for research, and
relevance of research questions.
(2) The originality of research, the extent to which it does not
replicate past or present research efforts (including ongoing efforts
not yet described in publications), and relevance to guiding current
HIV prevention efforts.
(3) Applicant's understanding of the research objectives as
evidence by high quality of the proposed research plan with a study
design that is appropriate to answer research questions.
(4) Feasibility of plans to sample, recruit, enroll, test,
interview, and follow study participants and adequacy of sample size to
address research questions. This includes demonstration of the
availability of HIV-infected potential study participants and persons
at risk for HIV infection and the experience of the investigator in
enrolling and following such persons in a culturally and linguistically
appropriate manner; the degree to which the applicant has met the CDC
Policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed research, including: (a) the proposed
plan for the inclusion of both sexes and racial and ethnic minority
populations for appropriate representation, (b) the proposed
justification when representation is limited or absent, (c) a statement
as to whether the design of the study is adequate to measure
differences when warranted, and (d) a statement as to whether the plans
for recruitment and outreach for study participants include the process
of establishing partnerships with community(ies) and recognition of
mutual benefits; comprehensiveness of the plan to protect the rights
and confidentiality of all participants; and proposed justification
when representation is limited or absent.
(5) Thoroughness of analysis plans, reasonableness for data
collected, statistical rigor and complexity.
(6) Extent to which study proposal demonstrates assurance of
compliance with multisite research requirements (e.g., common protocol,
data collection, and computer and data management systems), if
appropriate.
C. Demonstrate Staff's Capability to Conduct Research (20 Points)
(1) Capacity to conduct study as evidenced by experience with
similar or related research as evidenced by their previous related
research.
(2) Extent of the team's productive working relations with proposed
collaborators.
(3) Ability, willingness, and need to collaborate with researchers
from other study sites in study design and analysis, including use of
common forms, and sharing of specimens (when appropriate) and data.
D. Staffing, Facilities, and Time-line (15 Points)
(1) Availability of qualified personnel with realistic and
sufficient percentage-time commitments; and the clarity of the
description of duties and responsibilities of project personnel with
epidemiologic, behavioral, administrative, clinical, laboratory, data
management, and statistical responsibilities.
(2) Adequacy of the facilities, equipment, data processing and
analysis capacity, and systems for management of data security and
participant confidentiality.
(3) Adequacy of time line.
E. Other (not Scored)
(1) Budget: Will be reviewed to determine the extent to which it is
reasonable, clearly justified, consistent with the intended use of
funds, and allowable. All budget categories should be itemized.
(2) Human Subjects: Does the application adequately address the
institutional review board requirements for the protection of human
subjects?
________ Yes ________ No
Comments:--------------------------------------------------------------
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of
1. Annual progress report;
2. Financial status report, no more than 90 days after the end of
the budget period; and
3. Final financial status report and performance report, no more
than 90 days after the end of the project period send all reports to:
Kevin Moore, Grants Management Specialist, Grants Management Branch,
Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, N.E., Room 300, Mail Stop
E-15, Atlanta, GA 30305-2209.
For descriptions of the following Other Requirements, see
Attachment 1:
AR98-1 Human Subjects
AR98-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR98-4 HIV/AIDS Confidentiality Provisions
AR98-5 HIV Program Review Panel Requirements
AR98-6 Patient Care
AR98-7 Executive Order 12372 Review
AR98-8 Public Health System Reporting Requirements
AR98-9 Paperwork Reduction Act
AR98-10 Smoke-Free Workplace Requirements
[[Page 35592]]
AR98-11 Healthy People 2000
AR98-12 Lobbying Restrictions
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the Public Health Service Act,
Sections 301(a) and 317(k)(2) [42 U.S.C. 241(a) and 247b(k) (2)], as
amended. The Catalog of Federal Domestic Assistance number is 93.943.
J. Where To Obtain Additional Information
To receive additional written information and to request an
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked
to leave your name and address and to identify the Announcement number,
98035. If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from: Kevin Moore, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Announcement 98035, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, N.E.,
Room 300, Mail Stop E-15, Atlanta, GA 30305-2209, Telephone (404) 842-
6550, E-mail kgm1@cdc.gov.
See also the CDC Internet home page at: www.cdc.gov
For program technical assistance, contact: Jeff Efird, Acting
Chief, Epidemiology Branch, Division of HIV/AIDS Prevention
Surveillance & Epidemiology, National Center for HIV, STD, TB
Prevention Centers for Disease Control and Prevention (CDC) 1600
Clifton Road, NE., Mail Stop E-45, Atlanta, Georgia 30333, Telephone
(404) 639-6130, E-mail jle1@cdc.gov.
Eligible applicants are encouraged to call before developing and
submitting their applications.
Dated: June 23, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 98-17305 Filed 6-29-98; 8:45 am]
BILLING CODE 4163-18-P
